510(k) · Cleared
ClearedHydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol Inc., Sub. C. R. Bard, Inc. · HIG Insufflator, Hysteroscopic
Cleared on Feb 19, 1999 as substantially equivalent to K970078 (Davol Inc., Sub. C. R. Bard, Inc., 1997) and 1 other predicate after a 189-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 19, 1999
- Review
- 189 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933873 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK933873 Concept Universal Pump SystemLinvatec Corp. · 1994
- 1 generation backK970078 Hydrofloex HD Hysteroscopic Distention SystemDavol Inc., Sub. C. R. Bard, Inc. · 1997
- This deviceK982867 Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360…Davol Inc., Sub. C. R. Bard, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933873 | Concept Universal Pump System | Linvatec Corp. | 1994 | — |
| −1 | K970078 | Hydrofloex HD Hysteroscopic Distention System | Davol Inc., Sub. C. R. Bard, Inc. | 1997 | — |
| 0 (this device) | K982867 | Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000 | Davol Inc., Sub. C. R. Bard, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIG device
- #1 K261706 Endomat Select (UP220)score 14.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970078 | Hydrofloex HD Hysteroscopic Distention SystemSummary page 1…78) ~ Karl Storz Hamou Endomat® (K936231) The modified HydroFlex HD system described in this submission is substantially equivalent to the original HydroFlex HD system (K970078) and the Karl Storz Hamou Endomat (K936231). All of these devices are designed to provide distention and irrigation of the uterus… | 1997 |
| * | K936231 | The Karl Storz Hamou EndomatSummary page 1…n System Classification Name: Hysteroscopic Insufflator, Obstetrics & Gynecology - HydraFlex™ HD Hysteroscopic Distention System (970078) ~ Karl Storz Hamou Endomat® (K936231) The modified HydroFlex HD system described in this submission is substantially equivalent to the original HydroFlex HD system (… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIG
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIG
45in 2025
MAUDE reports naming product code HIG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 4 | 175 | 0 | 10 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982867 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982867: Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026